Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

NCT01436877 | Completed

• 1 other identifier: MT-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of MediTate Temporary Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck and prostatic urethra under local anesthesia for few days and taken out some 5 days later in the doctors office.

Conditions

Bladder Neck Obstruction; Benign Prostate Hyperplasia

Keywords

BPH; bladder neck obstruction; Bladder neck obstruction secondary to BPH

Outcome Measures

Primary Outcomes (1)

• Device related and unanticipated SAE

  Device related and unanticipated SAEs will be followed. No such SAEs are expected.

  At 3 months

Secondary Outcomes (2)

• Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects

  At 3 months

• Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects

  At 3 months

Study Arms (1)

device

EXPERIMENTAL

Insertion of Temporary Implantable Nitinol Device (TIND)

Device: Insertion of Temporary Implantable Nitinol Device (TIND)

Interventions

Insertion of Temporary Implantable Nitinol Device (TIND) DEVICE

Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.

device

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main IC:
• Subject signed informed consent prior to the performance of any study procedures.
• Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.
• IPSS symptom severity score ≥ 10.
• Peak urinary flow of \< 12 ml/sec
• No pathology found with kidney US
• Prostatic urethra length \< 30 mm
• Prostate volume \< 35 cc
• Normal Urinalysis and urine culture.

You may not qualify if:

• Main EC:
• Any prior prostate treatment
• Suspected or proved carcinoma of prostate
• Urethral stricture
• Urinary bladder stones
• Serum prostate specific antigen level \> 4 ng/ml (unless proved to be carcinoma free by biopsy).
• Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture.
• Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic lobe.
• Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever.
• Any serious medical condition likely to impede successful completion of the study
• Intraoperative EC:

Sponsors & Collaborators

• Medi-Tate Ltd.: lead

Study Sites (1)

Meir Medical center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Study Officials

• Roy Farfara, MD

  Bnai Zion Medical Center, Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2011
• First Posted: September 20, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

IL (1)